CMS Publishes Two Final Rules on Regulation of Health Care Providers – On May 10, 2012, CMS published two final rules on the regulation of health care providers. One rule modifies and eliminates Medicare and Medicaid regulations that CMS considers “unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries.” The other rule reforms certain Medicare and Medicaid conditions of participation (CoPs) for hospitals and critical access hospitals (CAHs). According to the accompanying Department of Health and Human Services (HHS) press release, the reforms will result in savings of almost $1.1 billion in the first year, and more than $5 billion over five years.
As described by CMS, the final rules will:
- Modify excessively burdensome regulations applicable to providers, including the elimination of the re-enrollment bar for providers who have had their billing privileges revoked for failing to timely respond to certain CMS requests.
- Retire obsolete or duplicative regulations, such as out-of-date infection-control requirements applicable to ambulatory surgical centers.
- Relax the governing body CoP requirement, allowing a single body to oversee multiple hospitals in a hospital system.
- Revise medical staff eligibility requirements, allowing hospitals to appoint non-physician practitioners to the medical staff.
- Allow CAHs to provide radiology and laboratory services, emergency procedures and other services through contracts with outside providers (i.e., non-CAH staff).
CMS will publish the final rules in the Federal Register on May 16, 2012. The rules will take effect 60 days after publication.
HHS’s press release on the final rules is available here.
Reporter, Greg Sicilian, Atlanta, +1 404 572 2810, gsicilian@kslaw.com.
CMS Issues Proposed Rule on Increasing Payment for Primary Care – On May 9, 2012, CMS issued a proposed rule that seeks to increase Medicaid payments for certain primary care services. Among other changes, the proposed rule:
- Implements the Affordable Care Act’s requirement that Medicaid reimburse primary care physicians for services CMS designates as “primary care services” at Medicare rates instead of state-established Medicaid rates (which often are lower) in calendar years (CYs) 2013 and 2014;
- Grants states more than $11 billion in federal funds over two years to support their Medicaid primary care delivery systems;
- Applies to primary care services delivered by physicians specializing in family medicine, general internal medicine, or pediatric medicine, and related subspecialists (as recognized by the American Board of Specialties); and
- Provides guidance on identification of eligible primary care services and providers, implementation of increased payments (including payments for services provided through managed care), and payment of vaccine administration fees under the Vaccine for Children program.
The temporary increase in payment for primary care services will be paid entirely by the federal government with no state matching of payment required. In particular, states will receive 100% Federal financial participation for the difference between the Medicaid state plan payment amount as of July 1, 2009, and the Medicare rates in effect in CYs 2013 and 2014 or, if greater, the payment rate that would be applicable using the CY 2009 Medicare conversion factor. According to a press release issued by CMS, the proposed rule “can help improve health and reduce costs by preventing illnesses before they happen and catching small problems before they turn into big ones.” The proposed regulations also note that, "[a]s we move towards CY 2014 and the expansion of Medicaid eligibility, it is critical that a sufficient number of primary care physicians participate in the [Medicaid] program," and these rate increases "will encourage primary care physicians to participate in Medicaid by increasing payment rates."
The proposed rule, available here, was published in the Federal Register on May 11, 2012. Comments are due by June 11, 2012. CMS has also issued a fact sheet to accompany the proposed rule.
Reporter, Jennifer S. Lewin, Atlanta +1 404 572 3569, jlewin@kslaw.com.
CMS Publishes Final Rule on Community First Choice Option – On May 7, 2012, CMS published a final rule on the Community First Choice (CFC) program. CFC is a new state Medicaid option—established by Section 2401 of the Affordable Care Act—under which participating states provide home and community-based attendant services and supports to certain Medicaid beneficiaries. The CFC option, according to CMS, allows beneficiaries to “self-direct” the services and supports they receive under the program, which include services “to assist [them] in accomplishing activities of daily living, instrumental activities of daily living, and health-related tasks.”
CMS explained in a summary of the final rule that it was issued to provide participating states “with additional flexibility to finance home and community-based attendant services and supports,” thereby expanding state and local program accessibility. Among other changes, the final rule:
- Provides that states implementing the CFC option are eligible to receive a 6 percentage point increase in their federal medical assistance percentages as long as they satisfy certain program requirements.
- Interprets the statutory requirements for CFC eligibility and clarifies that eligible beneficiaries must be deemed to need an institutional level of care to qualify for CFC services.
- Gives states the option to permanently waive annual recertification requirements for certain participants where there is no reasonable expectation of improvement in a participant’s condition.
- Sets out the services a state must provide under the program.
- Implements the requirement that, for the first full 12-month period during which a state implements the CFC option, the state must maintain or exceed the level of expenditures for home and community-based attendant services provided under the state plan, waivers or demonstrations for the preceding 12-month period.
The final rule, however, did not finalize the program’s “setting” requirements — i.e., it did not define “home or community” as used in the Affordable Care Act. CMS is seeking further public comment on that requirement in a separate proposed rule.
The final rule will take effect on July 6, 2012.
A CMS fact sheet accompanying the rule’s release is available here.
Reporter, Greg Sicilian, Atlanta, +1 404 572 2810, gsicilian@kslaw.com.
National Cybersecurity and Communications Integration Center Highlights Vulnerabilities in Healthcare Technology – In a recent bulletin, the National Cybersecurity and Communications Integration Center (NCCIC) at the U.S. Department of Homeland Security described the vulnerabilities associated with medical devices in the healthcare environment where wireless technology and networking are increasingly used. As many devices may be accessed through and connected to medical information technology networks, there are now concerns regarding theft of medical information and intrusion into networks through the devices. The NCCIC highlighted four factors that complicate security within a medical organization: (1) the current use of legacy devices placed in the market prior to the enactment of the Medical Device Law in 1976 when there was minimal testing on equipment; (2) failure to implement safety features on newer devices because of complexity of the technology; (3) budget constraints; and (4) failure to upgrade existing devices because they contain private information.
With technology rapidly changing, the healthcare arena is constantly challenged to keep up with the technology, especially because many medical devices now utilize wireless technology, may be linked to healthcare facility networks, and may be implantable within the body or otherwise portable. Furthermore, many healthcare professionals now utilize portable devices to monitor patients remotely. The NCCIC suggests a layered security approach to oversee this technology, with the following “best practices” noted, among others:
- Purchasing only those networkable medical devices which have well documented security features available, and which network engineers can configure safely on networks;
- Establishing strict policies for the connection of any networked devices, particularly wireless devices, to networks such that no access to networked resources is provided to unsecured and/or unrecognized devices;
- Using the principle of least privilege to decide which accounts need access to specific medical device segments, rather than providing access to the whole network; and
- Securing communications channels, especially wireless ones, by the use of encryption and authentication at both ends of a communication channel.
The bulletin, which may be accessed here, should be passed along to a healthcare organization’s IT network and technology specialists for review and discussion with organization executives.
Reporter, Christina A. Gonzalez, Houston, +1 713 276 7340, cagonzalez@kslaw.com.
This bulletin provides a general summary of recent legal developments. It is not intended to be and should not be relied upon as legal advice.
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